PERSPECTIVES

A view into statistical programming

Amy Gillespie, Executive Director and Head Statistical Programming at Merck

What is your current role at Merck?I joined Merck in June, 1997. I’ve worked in the industry for 20 years following a short career as a quantitative business analyst at Prudential Insurance Company. Since joining Merck, I’ve been working within the Biostatistics and Research Decisions Sciences organization as a statistical programmer. I’m currently heading the statistical programming organization which includes 194 statistical programmers located in the United States, Europe, and the Asia Pacific regions, I am also the business area sponsor of Accenture’s Life Sciences Cloud for R&D module Analysis & Reporting Workbench (ARW).

Can you tell us more about your current projects? One of my organization’s primary objectives is to update our standard operating processes and tools to be more aligned with regulatory and industry guidance. We are overhauling our standard macro library to simplify and streamline our code, expanding the implementation of data standards such as “Analysis Data Model” (ADaM) and installing tools to help our staff produce submission ready deliverables. Additionally we are rolling out a series of training classes to update our staff’s skills and knowledge in important, international clinical research standards (SDTM), technical writing and programming. All of these activities are in addition to implementing release 1 of the ARW, which will provide an integrated, traceable and compliant environment for statistical computing.

What type of results are you expecting from these improvements? The changes we are implementing in our department are taking us to the next level – it’s both challenging and motivating at the same time. It’s been a remarkable opportunity working with my staff to identify truly innovative solutions to modernize our statistical programming environment. I’m lucky to be surrounded by such talented individuals. It’s an exciting time to work at Merck and in our industry!

Speaking of our industry, what do you see in the future of life sciences?I’m very excited about the future of statistical programmers in the life sciences industry. We have both an opportunity and a responsibility to help make sense of the multitudes of data collected every day. From data collected in the clinic, electronic medical records, from insurance claims, medical devices, preclinical experiments and social media, statistical programmers have the tools and skillset to make a real difference.

What kind of changes do you see specifically in R&D?We must get better at evolving and implementing flexible, dynamic processes and tools. Besides the need to organize and quantify the growing amount of data being collected every day, my organization is simplifying our programs and processes to balance efficiency and simplicity. Black box programming is a thing of the past. Transparency and traceability is a must in our programming code. Programs must be written flexibly to accept changing CDISC data standards. Clients desire more data visualizations instead of line listings. Translating data and analysis results to different languages programmatically is emerging – manual translations takes too much time. Results are needed faster and faster – clients want results at their fingertips. All of this must be done without compromising quality and compliance.

What role can/should the Accenture Life Sciences Cloud for R&D play?As a Coalition we must leverage our diverse knowledge and combined voices to create innovative solutions for the Life Sciences industry. The Life Sciences Cloud Coalition hosted by Accenture is a group of like-minded partners from leading pharmaceutical and biotechnology companies collaborating in non-competitive areas for a healthier world. I’ve been working with other members of the ALSC for the last several months to define requirements for the “Analysis & Reporting Workbench." It’s exciting to collaborate with colleagues across the industry and I really feel our partnership will ultimately lead to a better product. At the end of the day however, Accenture must deliver on these challenging requirements and the sponsors must provide feedback on the solutions. Tool development is an evolution.

Name a place you have visited recently…At the end of May, I was in China to visit our colleagues in Beijing and Shanghai. This was my first time in China. In addition to visiting the new Merck site in Beijing and spending time with our statistical and statistical programming colleagues, I was able to visit Tiananmen Square, The Forbidden Palace, and the Great Wall.

What are your plans for your next day off?My husband and I just bought a cabin on Lake Wallenpaupack in the Poconos. Once we both get a day off we are heading up to our cabin so we can get our wave runners into the lake and enjoy some time on the water!